21 CFR Part 11
Subtitle: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Publisher: Informa Healthcare
Published: January 15, 2004
Language: eng
Format: Hardcover
Number of pages: 264
ISBN-13: 9780849322433
Subjects: Mathematics and Science; Science; General; Science/Mathematics; Verification; Industries - General; Medical / Pharmacology; Computer software; Chemistry - Analytic; Computer programs; Pharmaceutical industry; Validation
First sentence: FDA regulations require that domestic or foreign manufacturers of regulated products intended for commercial distribution in the United States, establish and follow controls as part of a quality assurance (QA) program.